Trial Outcomes & Findings for Stimgenics Open-Label, Post Market Study (NCT NCT03606187)

Last Updated: 2021-03-02

Results Overview

Percentage of Participants with a 50% decrease in back pain at 3 months compared to baseline. Pain rating will be measured on the 10 cm Visual Analog Scale (VAS). Change in back pain score will be used to determine individual responder (e.g., 50% reduction in VAS compared to Baseline VAS).

Recruitment status

COMPLETED

Study phase

Target enrollment

128 participants

Primary outcome timeframe

3 months

Results posted on

2021-03-02

Participant Flow

Participant milestones

Participant milestones
Measure	Test Arm Subjects randomized to this arm will receive test treatment Stimgenics SCS Programming Approach: Stimgenics SCS Programming approach Using Intellis(TM) SCS system	Control Arm Subjects randomized to this arm will receive control treatment Standard SCS Programming Approach: Standard SCS Programming approach Using Intellis(TM) SCS system
Overall Study STARTED	67	61
Overall Study COMPLETED	67	61
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stimgenics Open-Label, Post Market Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Arm n=67 Participants Subjects randomized to this arm will receive test treatment Stimgenics SCS Programming Approach: Stimgenics SCS Programming approach Using Intellis(TM) SCS system	Control Arm n=61 Participants Subjects randomized to this arm will receive control treatment Standard SCS Programming Approach: Standard SCS Programming approach Using Intellis(TM) SCS system	Total n=128 Participants Total of all reporting groups
Age, Continuous	61.25 years STANDARD_DEVIATION 12.16 • n=5 Participants	60.66 years STANDARD_DEVIATION 11.77 • n=7 Participants	60.98 years STANDARD_DEVIATION 11.93 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	34 Participants n=7 Participants	68 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	27 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	60 Participants n=5 Participants	50 Participants n=7 Participants	110 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Back Pain	7.25 cm STANDARD_DEVIATION 1.49 • n=5 Participants	7.35 cm STANDARD_DEVIATION 1.26 • n=7 Participants	7.3 cm STANDARD_DEVIATION 1.38 • n=5 Participants
Leg Pain	6.2 cm STANDARD_DEVIATION 2.58 • n=5 Participants	6.58 cm STANDARD_DEVIATION 2.06 • n=7 Participants	6.38 cm STANDARD_DEVIATION 2.35 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Intent to treat population (all subjects randomized)

Outcome measures

Outcome measures
Measure	Test Arm n=67 Participants Subjects randomized to this arm will receive test treatment Stimgenics SCS Programming Approach: Stimgenics SCS Programming approach Using Intellis(TM) SCS system	Control Arm n=61 Participants Subjects randomized to this arm will receive test treatment Standard SCS Programming Approach: Standard SCS Programming approach Using Intellis(TM) SCS system
The Percentage of Individual Responders	80.9 percentage of responders Interval 69.0 to 89.6	50.9 percentage of responders Interval 39.1 to 62.6

SECONDARY outcome

Timeframe: 3 months

The percentage of Individual Responders (50% reduction in pain score rated on a Visual Analog Scale); Test for superiority

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Comparison of change from Baseline in back pain score (using Visual Analog Scale 0.0-10.0cm) determined at the 3- and 6-month visit after device activation, between test and control in a statistical test of non-inferiority. This is calculated as: Change from Baseline in Back Pain VAS = 3-Month Visit Pain VAS - Baseline Pain VAS.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Comparison of Back Pain Treatment Success (responder rate), measured as subjects with at least a 50% reduction in Back Pain Visual Analog Scale (VAS), evaluated at 6 months after device activation, between test and control

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Oswestry Disability Index (ODI) evaluated at 3 months visit

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Frequency of treatment emergent adverse events

Outcome measures

Outcome data not reported

Adverse Events

Test Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Arm

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Test Arm n=67 participants at risk Subjects randomized to this arm will receive test treatment Stimgenics SCS Programming Approach: Stimgenics SCS Programming approach Using Intellis(TM) SCS system	Control Arm n=61 participants at risk Subjects randomized to this arm will receive test treatment Standard SCS Programming Approach: Standard SCS Programming approach Using Intellis(TM) SCS system
Infections and infestations Implant Site Infection	0.00% 0/67 • 1 year Adverse events related to the study is collected.	1.6% 1/61 • Number of events 1 • 1 year Adverse events related to the study is collected.
General disorders Medical device site pain	0.00% 0/67 • 1 year Adverse events related to the study is collected.	1.6% 1/61 • Number of events 1 • 1 year Adverse events related to the study is collected.

Other adverse events

Adverse event data not reported

Additional Information

VP of Clinical Affairs

SGX Medical

Phone: 6613108409

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place